Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
This study is currently recruiting participants.
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Shannon MacDonald, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01340495
First received: April 20, 2011
Last updated: April 22, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.
| Condition | Intervention |
|---|---|
|
Invasive Breast Cancer |
Radiation: Proton Radiation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 toxicity within 3 months after the completion of radiation treatment.
Secondary Outcome Measures:
- To evaluate the rate and severity of acute skin toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate the rate and severity of radiation pneumonitis, a sub-acute toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate the rate and severity of late skin toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate cosmetic outcome and patient satisfaction with cosmetic outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To evaluate acute and late toxicity of breast reconstruction following proton radiation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate the need for unplanned additional surgery for breast reconstruction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate early signs of cardiac effects from radiation therapy using Strain Echocardiogram [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]To describe the 5 year progression free survival rate of patients with breast cancer treated with proton radiation
| Estimated Enrollment: | 52 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Radiation: Proton Radiation
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.
Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
- Life expectancy > 12 months
Exclusion Criteria:
- Pregnant or breast-feeding
- Prior therapeutic radiation > 200 cGy
- History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
- Prior investigation chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340495
Contacts
| Contact: Shannon M MacDonald, M.D. | 617-729-8650 | smacdonald@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Shannon M MacDonald, MD | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Shannon M MacDonald, M.D. | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Shannon MacDonald, MD, Attending Radiation Oncologist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01340495 History of Changes |
| Other Study ID Numbers: | 10-205 |
| Study First Received: | April 20, 2011 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Breast Cancer Mastectomy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013